FDA approves Aurobindo’s generic Dilaudid

SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo Pharma’s generic version of Dilaudid (hydromorphone HCl) tablets, the company announced Wednesday. The drug is indicated to relieve moderate to severe acute pain in patients for whom opioid use is appropriate. 

 

Aurobindo’s hydromorphone tablets will be available in 2-, 4- and 8-mg dosage strengths. The product had an estimated market size of $49.3 million fo the 12 months ended April 2016, according to IMS Health.